Availability of large-scale evidence on specific harms from systematic reviews of randomized trials
Availability of large-scale evidence on specific harms from systematic reviews of randomized trials
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DOI：
10.1016/j.amjmed.2004.04.026
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发表时间：
2004-10-15
影响因子：
5.9
通讯作者：
Ioannidis, JPA
中科院分区：
文献类型：
--
作者：
Papanikolaou, PN;Ioannidis, JPA
目得：为了评估如何频繁的随机对照试验的系统评价传达大规模的证据，具体的，明确的不良事件。方法：我们搜索了科克伦数据库的系统评价的评论包含定量数据的具体的，明确的危害至少4000名随机受试者，足够的权力，以检测不良事件所需的最小样本，由于干预在1%的受试者。主要结果指标包括符合条件的大规模不良事件数据的审查数量，不符合条件的审查数量，以及基于大规模evidence.RESULTS的记录危害的程度（绝对风险，相对风险）：在1727篇审查中，138篇包括大于或等于4000名受试者的证据。只有25例（18%）有合格的不良事件数据，77例没有伤害数据，36例有非特定或相关的伤害数据
PURPOSE: To assess how frequently systematic reviews of randomized controlled trials convey large-scale evidence on specific, well-defined adverse events.METHODS: We searched the Cochrane Database of Systematic Reviews for reviews containing quantitative data on specific, well-defined harms for at least 4000 randomized subjects, the minimum sample required for adequate power to detect an adverse event due to an intervention in 1% of subjects. Main outcome measures included the number of reviews with eligible large-scale data on adverse events, the number of ineligible reviews, and the magnitude of recorded harms (absolute risk, relative risk) based on large-scale evidence.RESULTS: Of 1727 reviews, 138 included evidence on greater than or equal to4000 subjects. Only 25 (18%) had eligible data on adverse events, while 77 had no harms data, and 36 had data on harms that were nonspecific or pertained to